FDA.reportPublic FDA data

Fielmann

Primary DI
04066209042575
Brand
Fielmann
Company
Fielmann Group AG
Model
MC 561 SUN CL VINCENT_24787
Published
2025-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04066209042575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066209042575040662090425754066209042575

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312583602
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04066209006799FielmannBD 404 MOD FLEX CL_213272026-07-14
04066209008311FielmannBD 457 FLEX CL_211112026-07-14
04066209008885FielmannBD 480 FA_221992026-07-14
04066209045118FielmannBD 550 CL_251812026-07-14
04066209054578FielmannBD 464 MOD CL_281822026-07-14
04066209026032FielmannMI 029 CL_211372026-07-08
04066209033016FielmannCOMFORT 117 CL_227042026-07-08
04066209033184FielmannJIL 018 CL_227602026-07-08
04066209040083FielmannTITANIUM 199 FLEX CL_241612026-07-08
04066209044883FielmannMF 057 RN_251652026-07-08
04066209046917FielmannCOMFORT 129 FLEX CL_254232026-07-08
04066209046924FielmannCOMFORT 129 FLEX CL_254232026-07-08
04066209047051FielmannJIL 009 CL_254272026-07-08
04066209049178FielmannTITANIUM 206 CL UWE_257452026-07-08
04066209051140FielmannJIL 033 FLEX CL_276092026-07-08
04066209051201FielmannJIL 032 FLEX CL_276182026-07-08
04066209052475FielmannBE 032 FA_279342026-07-08
04066209052673FielmannABC 080 FLEX CL KIM_279762026-07-08
04066209052697FielmannABC 080 FLEX CL KIM_279752026-07-08
04066209052932FielmannABC 079 FLEX FA AMANDA_279852026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580822704165EYEVANEYEVAN INC.HQY2026-07-10
04580822704172EYEVANEYEVAN INC.HQY2026-07-10
04580822704189EYEVANEYEVAN INC.HQY2026-07-10
04580822704196EYEVANEYEVAN INC.HQY2026-07-10
04580822704660EYEVANEYEVAN INC.HQY2026-07-10
04580822704677EYEVANEYEVAN INC.HQY2026-07-10
04580822704684EYEVANEYEVAN INC.HQY2026-07-10
04580822704691EYEVANEYEVAN INC.HQY2026-07-10
04580822704707EYEVANEYEVAN INC.HQY2026-07-10
04580822705148EYEVANEYEVAN INC.HQY2026-07-10
04580822705155EYEVANEYEVAN INC.HQY2026-07-10
04580822705162EYEVANEYEVAN INC.HQY2026-07-10
04580822705179EYEVANEYEVAN INC.HQY2026-07-10
04580822705186EYEVANEYEVAN INC.HQY2026-07-10
04580822705193EYEVANEYEVAN INC.HQY2026-07-10
04580822705223EYEVANEYEVAN INC.HQY2026-07-10
04580822705230EYEVANEYEVAN INC.HQY2026-07-10
04582669067885E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067892E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067908E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067915E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067922E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068417E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068424E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068455E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068462E5 eyevanEYEVAN INC.HQY2026-07-10
04582669069384EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069391EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069407EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069582EYEVAN7285EYEVAN INC.HQY2026-07-10